All Times EDT
Keywords: Propensity score-based methods, Leveraging external data, Historical clinical study data, Real-World data
The world of medical devices while highly diverse is tremendously innovative and this facilitates the adoption of innovative statistical techniques. The statistical innovations include the incorporation of Bayesian methods and adaptive designs in medical device clinical trials, the adoption and advancement of propensity score methodology in the design and analysis of non-randomized observational studies, the introduction of tipping point analysis for missing data, statistical methods for the design and analysis of companion diagnostic studies, and the application of artificial intelligence and machine learning for the development and evaluation of digital health technology. This presentation will focus on the advancement and implementation of novel propensity score-based methods that can be utilized in the regulatory clinical studies including those leveraging external data such as historical clinical study data and real-world data.